Prospective Observational Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 18
- 主要终点
- Cardiotoxicity
研究概览
简要总结
All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.
详细描述
The study was designed as a prospective observational multicenter study to evaluate the role of possible early markers of cardiotoxicity estimating an overall maximum risk equal to 20% of patients. The sample size, required to obtain an estimate of conventional anthracycline cardiotoxicity in the population, has been calculated with a confidence interval of 95% and a maximum acceptable error of ± 0.075. According to the conditions described above, the sample size of patients treated with conventional anthracycline results to be 124 patients.
Considering a 10-15% of not evaluable patients, the sample size is fixed at 150 patients treated with R-CHOP. The duration of the enrollment phase is defined in 2 years.
With this sample size should be possible to assess the risk of cardiotoxicity related to predictors with a worst group frequency at least of 10%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Diffuse Large B-Cell Lymphoma diagnosis
- •Patient eligible to receive 6 cycles of R-CHOP or R-CHOP like chemotherapy at full doses
- •Stage I-IV
- •Written informed consent
- •ECOG Performance Status 0-3
- •Ventricular Ejection Fraction (VEF) ≥40%
- •No previous treatment for lymphoma (except for RT-IF)
- •Negative β-HCG pregnancy test result at diagnosis for female of childbearing potential
- •Use of acceptable method of contraception during the study and for 3 months after receiving the last dose of study drug for patients with childbearing potential
- •Availability of the patient to be followed for all the phases of the chemotherapy treatment and for the subsequent follow-up
排除标准
- •Inability to schedule a treatment at full doses of chemoimmunotherapy R-CHOP or R-CHOP-like for different reasons
- •Central nervous system involvement due to lymphoma
- •Active cardiac pathology including heart failure, left ventricular dysfunction documented by a LVEF <40%, arrhythmias (rapid atrial fibrillation, frequent ventricular arrhythmias), valvular aortic or mitral disfunction > moderate, ischemic heart disease (myocardial infarction or acute coronary syndrome for over 6 months, angina at rest or with mild efforts)
- •Previous treatment for lymphoma
- •Other malignancy in the 3 years prior to the diagnosis of lymphoma with exception of non-melanoma skin cancer or in situ carcinoma
- •Any other co-existing medical condition that would preclude participation in the study (uncontrolled bacterial or viral or fungal infection)
- •Pregnant, or lactating and breastfeeding female
研究组 & 干预措施
Chemo immunotherapy
All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.
干预措施: R-CHOP with doxorubicin (Drug)
结局指标
主要结局
Cardiotoxicity
时间窗: 1 year from enrollment
defined as the rate of cardiovascular events classified according to the Lenihan criteria 2013
次要结局
- Overall response rate (ORR)(6 months from enrollment)
- Rate of response to treatment(6 months from enrollment)
- Overall survival (OS)(3 years from enrollment)
- Progression-free survival (PFS)(3 years from enrollment)
- failure-free survival (FFS)(3 years from enrollment)
- Freedom From cardiovascular Event (FFCE)(3 years from enrollment)
- Number of events recorded during the treatment and codified according to NCI-CTC v4.03(3 years from enrollment)